Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The Mean Prescribed Budesonide Dose (μg) at Baseline
研究概览
简要总结
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.
详细描述
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.
The study comprised 4 phases:
During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.
During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.
During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omalizumab + budesonide and formoterol
Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.
干预措施: Omalizumab (Drug)
Omalizumab + budesonide and formoterol
Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.
干预措施: Budesonide (Drug)
Omalizumab + budesonide and formoterol
Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.
干预措施: Formoterol (Drug)
Budesonide and formoterol
Participants will receive budesonide and formoterol according to maximum daily dose.
干预措施: Budesonide (Drug)
Budesonide and formoterol
Participants will receive budesonide and formoterol according to maximum daily dose.
干预措施: Formoterol (Drug)
结局指标
主要结局
The Mean Prescribed Budesonide Dose (μg) at Baseline
时间窗: Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
次要结局
- Number of Hospital Admissions Due to Asthma Exacerbation(12 month treatment duration)
- Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration(12 month treatment duration)
- Control of Asthma Symptoms- Daytime Symptoms(12 month treatment duration)
- Days Missed in School/Work Due to Asthma Exacerbation Episodes(12 month treatment duration)
- Control of Asthma Symptoms(12 month treatment duration)
- Control of Asthma Symptoms- Rescue Medication Use(12 month treatment duration)
- Asthma Control Questionnaire (ACQ) at Baseline(Baseline)
- Asthma Quality of Life Questionnaire (AQLQ) at Baseline(Baseline)